AB1487 VALIDATION AND CULTURAL ADAPTATION OF THE QUALISEX QUESTIONNAIRE IN WOMEN WITH SJÖGREN’S SYNDROME IN ITALY
Authors: F. Giardina, G. Curcio, C. Gioia, R. Izzo, E. Simoncelli, A. Gattamelata, S. Colafrancesco, L. Mastromanno, M. Villa, C. Iannuccelli, M. Di Franco, F. Conti, R. Priori
Journal: Annals of the Rheumatic Diseases (2022)

Background The quality of sexual life (QSL) is a complex and multimodal experience influenced by endogenous and external factors, including age, gender, and cultural environment. Rheumatic diseases, with their burden of pain, fatigue, organ damage, and disability, can severely impair sexual life and this is true also for Sjögren’s Syndrome, where simple tools to assess the QSL in everyday clinical practice are needed. Objectives To translate ad adapt into Italian the Qualisex, a new brief questionnaire originally created for Rheumatoid Arthritis patients, for women with primary Sjögren’s Syndrome (pSS) and evaluate the impact of the disease on their sexuality. Methods Consecutive sexually active pSS (according to ACR/EULAR 2016 criteria) patients aged &gt;18 were asked to participate in this study approved by the local bioethics committee. With the permission of the developer, the French original version of the Qualisex questionnaire (consisting of 10 items, the higher the score, the greater the negative impact of the disease on the QSL) was translated and adapted into Italian according to current guidelines. In the absence of a gold standard assessment for sexuality in pSS, face and content validity was assessed cross-sectionally by correlations with other disease aspects such as anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS), EULAR SS patient-reported index (ESSPRI), and quality of the relationship. As a measure of reliability, internal consistency was assessed through Cronbach’s Alpha coefficient. A Cronbach’s value &gt;0.7 is generally regarded as satisfactory. The feasibility of the scale was indirectly assessed through missing data. To assess the factorial structure of the Italian version of the questionnaire an Exploratory Factor Analysis (EFA) was carried out. Moreover we also assessed the level of redundancy by means of intra-item correlation of the Qualisex questionnaire. ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index), and SSDDI (Sjogren’s Syndrome Disease Damage Index) were assessed as well. Analyses were carried out with IBM SPSS Statistics for Macintosh, version 22.0 (IBM Corp., Armonk, NY, USA). Results 40 sexually active women with pSS and a median age of 53 (IQR 45.25-57.25) were enrolled. The EFA showed that the model with a single factor appeared to be highly significant (Chi235= 2943.10; p&lt;0.05); the average inter-item correlation was found to be 0.392 (Min -0.479; Max 0.834) which is an acceptable value as for redundancy. There were no missing answers. Cronbach’s alpha coefficient resulted to be 0.86 which indicates an adequate internal consistency. The median Qualisex score was 4.65 (IQR 2.13–6.2). As far as correlations, age (Rho=0.39; p&lt;0.05), menopause (Rho=0.41; p&lt;0.05), relationship quality (Rho=0.55; p&lt;0.05), anxiety (HADS-A; Rho=0.38; p&lt;0.05), and depression (HADS-D; Rho=0.47; p&lt;0.05) appeared to be positively correlated with Qualisex score. Also, a positive correlation with ESSPRI (Rho=0.43; p&lt;0.05), and drug use (Rho=0.37; p&lt;0.05) was demonstrated. On the contrary no significant correlation was found with education (Rho=-0.07; p=0.64), systemic disease activity (Rho=0.14; p=0.39), and damage (Rho=0.06; p=0,74). Conclusion The Italian version of the Qualisex questionnaire is a valid, reliable and useful tool to assess the quality of sexual life in pSS. QSL in pSS women has an inverse relationship with age, menopause, drug use, ESSPRI, mood disorders, and dissatisfaction with the partner, while, as previously reported, no correlation was found with disease activity, damage, and educational status. This further highlights the impact of subjective symptoms such as dryness, pain, fatigue, and the overall psychological well-being on patients’ life. Thus, it is critical for the physician to consider patients’ perspective. Disclosure of Interests None declared